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Nucynta ER Side Effects

Generic name: tapentadol

Medically reviewed by Drugs.com. Last updated on Mar 29, 2021.

Note: This document contains side effect information about tapentadol. Some of the dosage forms listed on this page may not apply to the brand name Nucynta ER.

For the Consumer

Applies to tapentadol: oral conventional tablets, oral extended-release tablets, oral oral solution

Warning

    Addiction, Abuse, and Misuse
  • Risk of addiction, abuse, and misuse, which can lead to overdosage and death.1 20 21 Assess each patient’s risk for addiction, abuse, and misuse before prescribing tapentadol; monitor all patients regularly for development of these behaviors or conditions.1 20 21 (See Addiction, Abuse, and Misuse under Cautions.)

    Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur.1 20 21 Monitor for respiratory depression, especially during initiation of therapy and following dosage increases.1 20 21 (See Respiratory Depression under Cautions.)

  • Patients must swallow extended-release tablets whole to avoid exposure to a potentially fatal dose.21

    Accidental Exposure
  • Accidental ingestion of even 1 dose, especially by a child, can result in a fatal overdose.1 20 21

    Neonatal Opiate Withdrawal
  • Prolonged maternal use of opiates during pregnancy can result in neonatal withdrawal syndrome, which may be life-threatening if not recognized and treated.1 20 21 Advise women who require such therapy during pregnancy of this risk and ensure appropriate treatment will be available.1 20 21 (See Pregnancy under Cautions.)

    Concomitant Use with Benzodiazepines or Other CNS Depressants
  • Concomitant use of opiate agonists with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.1 20 21 416 417 418 700 701 702 703

  • Reserve concomitant use of opiate analgesics and benzodiazepines or other CNS depressants for patients in whom alternative treatment options are inadequate; use lowest effective dosages and shortest possible duration of concomitant therapy and monitor closely for respiratory depression and sedation.1 20 21 700 703 (See Specific Drugs under Interactions.)

    Medication Errors with Oral Solutions
  • Potential for medication errors due to confusion between mg and mL; can result in inadvertent overdosage and death.20 Ensure accuracy in prescribing, dispensing, and administration.20 (See Oral Solution under Dosage and Administration.)

    Interaction with Alcohol
  • Consuming alcohol while receiving tapentadol extended-release tablets could result in increased plasma concentrations of the drug and a potentially fatal overdose; patients must not consume alcoholic beverages or take alcohol-containing prescription or nonprescription preparations during therapy with extended-release tablets.21

REMS:

FDA approved a REMS for tapentadol to ensure that the benefits outweigh the risk. The REMS may apply to one or more preparations of tapentadol and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page ([Web]).

Side effects include:

Nausea, dizziness, vomiting, somnolence, constipation, pruritus, dry mouth, hyperhidrosis, fatigue, headache, vomiting, diarrhea, decreased appetite, anxiety, insomnia, dyspepsia, hot flush. In several clinical studies, adverse GI effects (nausea, vomiting, constipation) reported more commonly with oxycodone than with tapentadol (the active ingredient contained in Nucynta ER)

For Healthcare Professionals

Applies to tapentadol: oral tablet, oral tablet extended release

General

The most common adverse reactions were nausea, dizziness, vomiting, constipation, headache, and somnolence.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 30%), vomiting (up to 18%), constipation (up to 17%)

Common (1% to 10%): Dry mouth, dyspepsia, diarrhea, abdominal discomfort

Rare (less than 0.1%): Impaired gastric emptying[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 24%), headache (up to 15%), somnolence (up to 15%)

Common (1% to 10%): Tremor, lethargy, vertigo, disturbance in attention, sedation, hypoesthesia

Uncommon (0.1% to 1%): Memory impairment, mental impairment, syncope, balance disorder, dysarthria, paresthesia, depressed level of consciousness, presyncope, ataxia

Rare (less than 0.1%): Convulsion, coordination abnormal

Frequency not reported: Seizure, serotonin syndrome[Ref]

Psychiatric

Common (1% to 10%): Insomnia, confusion, abnormal dreams, anxiety, depression, irritability, nervousness, drug withdrawal syndrome, restlessness, sleep disorder, hallucination, depressed mood

Uncommon (0.1% to 1%): Disorientation, agitation, perception disturbances, euphoric mood, nightmare

Rare (less than 0.1%): Thinking abnormal, drug dependence

Postmarketing reports: Suicidal ideation, panic attack[Ref]

Other

Common (1% to 10%): Fatigue, asthenia, chills, edema, feeling hot, feeling cold, feeling of body temperature change, mucosal dryness

Uncommon (0.1% to 1%): Feeling abnormal, feeling drunk, feeling of relaxation[Ref]

Dermatologic

Common (1% to 10%): Pruritus, hyperhidrosis, pruritus generalized, rash, flushing

Uncommon (0.1% to 1%): Urticaria

Postmarketing reports: Angioedema[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea

Uncommon (0.1% to 1%): Respiratory depression, oxygen saturation decreased, cough[Ref]

Cardiovascular

Common (1% to 10%): Hot flush, hypotension

Uncommon (0.1% to 1%): Heart rate increased, heart rate decreased, blood pressure decreased, palpitations, left bundle branch block[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, erectile dysfunction

Uncommon (0.1% to 1%): Urinary hesitation, pollakiuria, sexual dysfunction[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, involuntary muscle contractions, muscle spasms

Uncommon (0.1% to 1%): Bone pain, sensation of heaviness[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Uncommon (0.1% to 1%): Weight decreased[Ref]

Ocular

Common (1% to 10%): Vision blurred

Uncommon (0.1% to 1%): Visual disturbance[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Anaphylaxis, anaphylactic shock[Ref]

Hepatic

Uncommon (0.1% to 1%): GGT increased, ALT increased, AST increased[Ref]

Frequently asked questions

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Nucynta (tapentadol)." PriCara Pharmaceuticals (2009):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.